EligibleTrials

The Effects of Metabolic & Bariatric Surgery on Lipid Metabolism, Myeloid-Derived Suppressor Cells, and Cancer Cell Biology

Recruiting · NCT06059651 · Observational (researchers observe without assigning treatment) · Lead sponsor: Pennington Biomedical Research Center

View the official record on ClinicalTrials.gov →
Obesity

Interventions studied

Metabolic & Bariatric Surgery

What this trial is about

This study aims to determine the relationship between lipid kinetics changes and blood immunosuppressive cells by metabolic surgery in two patient cohorts.

Who can take part

Age range
35 Years to 60 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)

Eligibility criteria (as published)

For an eligible subject, all the following must be answered "yes": * Biological female sex * Age \>=35 and \<=60 years (including pre- and postmenopausal) * Self-reported white or black race * The study will enroll approximately 50% white and 50% black subjects * Body mass index \>/=40 kg/m2 * Have a diagnosis of hyperlipidemia (high triglycerides and LDL-cholesterol) or in treatment with any medication for hyperlipidemia at enrollment * Ability to provide written informed consent * Allow the collection and storage of biospecimens and data for future use * Not having yet started the pre-op liquid diet before the bariatric surgery For an eligible subject, all the following must be answered "no": * Have type one or type two diabetes * Use of anti-inflammatory medications, such as glucocorticoids or non-steroidal anti-inflammatory medications, within the past 15 days * Use of medication approved for obesity management, including, but not limited to, phentermine-topiramate (Qsymia), orlistat (Xenical), naltrexone-bupropion (Contrave), liraglutide (Saxenda), and semaglutide (Wegovy) * History of cancer of any type * History of chronic conditions known to cause inflammation, such as tuberculosis, autoimmune disease, and human immunodeficiency virus * An acute history (within the past 60 days) or confirmed or suspected SARS-CoV-2 (COVID-19) infection * Currently pregnant, breastfeeding, or planning to become pregnant within the next 52 weeks * Currently participating in another study with competing outcomes * Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol

Where it is running

1 location listed across 1 US state.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →

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